CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
IontoPatch 80, On-the-Go Patch Therapy recalled by LTS Therapy Systems
LTS Therapy Systems is recalling IontoPatch 80, On-the-Go Patch Therapy, distributed nationwide in the US. The recall was initiated on 22 May 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2197-2025
- FDA event ID
- 97146
- Recalling firm
- LTS Therapy Systems, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 May 2025
- FDA classified
- 29 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 May 2025 | Recall initiated by company | |
| 29 Jul 2025 | Classified by FDA | +68 days |
| 6 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Product as listed by the FDA
IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; The IontoPatch is an Iontophoresis transdermal patch.
Where it was distributed
US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
Nationwide IllinoisIndianaKentuckyMinnesotaNew JerseyNew YorkOhioSouth DakotaTennessee
Questions about this recall
Why was it recalled?
The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device.
Which lots are affected?
Lot Code: UDI-DI: (01) 10815611020012 UDI-PI: (10) 4303 Lot numbers: 4303-1, 4303-2, 4303-3
Where was it sold?
US Nationwide distribution in the states of Indiana, Tennessee, New York, Minnesota, New Jersey, Ohio, Kentucky, Illinois, and South Dakota.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97146| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IontoPatch STAT, On-the-Go Patch Therapy recalled by LTS Therapy Systems | LTS Therapy Systems | Other | Nationwide |
More recalls from LTS Therapy Systems
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IontoPatch STAT, On-the-Go Patch Therapy recalled by LTS Therapy Systems | LTS Therapy Systems | Other | Nationwide |
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